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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Serum Zinc May Be Useful Marker With Alopecia
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T2 Biosystems Shifts Paradigm for Rapid Pathogen Identification Directly From Sample
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Sequencing of Sperm RNA May Improve Diagnosis of Male Infertility
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Latest Fraud Takedown and CMS Fraud Detection Strategies Yield Big Returns
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Whistleblower Employees May Not Have Carte Blanche to Confidential Information
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AG’s Office Offers Compliance Tips While Noting New Enforcement Strategies
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Outcome of LDT Regulation Controversy Defies Forecasting
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Medicare and Medicaid Turn 50 Years Old This Week
By Kelly A. Briganti, Editorial Director, G2 Intelligence This week, on July 30, Medicare and Medicaid celebrate a 50th birthday. On that date in 1965, President Lyndon B. Johnson signed legislation establishing those federal health insurance programs. The Centers...
Incorporating HIE Data into Care Cuts Use of Lab Tests
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Leveraging clinical data from a health information exchange (HIE) can significantly reduce the number of duplicate laboratory tests and radiology assessments performed in the emergency room,...
Magellan Obtains FDA Approval for Point-Of-Care Lead Test
By Ron Shinkman, Editor, Laboratory Industry Report Magellan Diagnostics has received 510(k) regulatory approval from the U.S. Food and Drug Administration to market a new point-of-care test that would be used to test lead levels in blood. The test, known as...